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Baxter Healthcare Corporation

Baxter Healthcare Corporation Recalls

All product recalls associated with Baxter Healthcare Corporation.

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Recall Summary

Total Recalls

1000

Past Year

566

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4021–4040 of 7756 recalls

Sevoflurane (Baxter Healthcare) – stability specification failure (2019)

Failed Stability Specifications

Class IIModerate

FDAJun 13, 2019Nationwide• Baxter Healthcare Corporation

Beckman Coulter Inc.: SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Cat...

The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.

FDAJun 12, 2019Nationwide• Beckman Coulter Inc.

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: Human Assayed Multi-Sera Level 2, Model NO. HN1530 Pro...

The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

1...200 201202203 204...388

Page 202 of 388Next

FDAJun 11, 2019Nationwide• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

AmazonBasics Ceramic Space Heaters – Fire Hazard (2019)

Fire/Burn Risk

This recall involves AmazonBasics 1500 watt ceramic space heaters. Two models (ASIN B074MR2HGM and ASIN B074MWRLZM) have oscillating fans and the others (ASIN B074MX8VNR and ASIN B074MWKSLX) do not. The heaters were sold in black and silver colors. The AmazonBasics logo is printed on the front of the units. The following ID numbers are printed on the label on the back of the units: B074MWKSLX, B074MX8VNR, B074MR2HGM, B074MWRLZM.

CPSCJun 11, 2019Nationwide• Ningbo Singfun Electric Appliance Co., Ltd., of China

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: Assayed Bovine Multi-Sera Level 1, Model No. AL1027

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

FDAJun 10, 2019AZ, OR, VA +2 more• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Parivar Dry Dates – High Sulfite Levels (2019)

Product contains high levels of sulfites

Class IHigh

FDAJun 7, 2019FL, GA, IN +2 more• DILIP CERAMICS DBA SHIVAM DISTRIBUT

DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany: DRG Salivary Progesterone HS ELISA- IVD for the determina...

Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.

FDAJun 6, 2019Nationwide• DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany

Whole Jalapeno (Shelton Farms) – Salmonella contamination (2019)

Salmonella

Class IHigh

FDAJun 3, 2019IN, MI• Shelton Farms dba Shelton's Wholesale Co

Baxter Healthcare Corporation: REVACLEAR 400 Dialyzer, Product Code 114746L Revaclea...

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

FDAMay 31, 2019Nationwide• Baxter Healthcare Corporation

Baxter Healthcare Corporation: REVACLEAR 300 Dialyzer, Product Code 114745L Revaclea...

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

FDAMay 31, 2019Nationwide• Baxter Healthcare Corporation

Boston Scientific Neuromodulation Corporation: Nitinol Thermocouple Electrode, 10 cm - Product Usage: Th...

The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.

FDAMay 30, 2019Nationwide• Boston Scientific Neuromodulation Corporation

Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom: Quantum Pump Console

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

FDAMay 29, 2019NY, OH, VA +1 more• Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom

Abbott Laboratories: ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITEC...

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

FDAMay 24, 2019Nationwide• Abbott Laboratories

Abbott Laboratories: ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT ...

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

FDAMay 24, 2019Nationwide• Abbott Laboratories

Pineapple Corer & Slicer (Fabulous Home) – laceration risk (2019)

Laceration Risk

This recall involves Pineapple Corer & Slicers sold under Fabulous Home brand. The corer & slicer is white with a black top and made mostly from plastic with a metal blade. It works much like a cork screw to core and slice pineapples.

CPSCMay 23, 2019Nationwide• Ningbo Overpass International Trading Co., Ltd, of China.

Obalon Therapeutics Inc: Obalon Balloon System with Model 4300 Touch Dispenser Tou...

During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.

FDAMay 23, 2019Nationwide• Obalon Therapeutics Inc

Abbott Laboratories: "HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R0...

Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.

FDAMay 22, 2019Nationwide• Abbott Laboratories

Havoc ROV (Arctic Cat) – Crash Hazard (2019)

This recall involves all model year 2018 and 2019 Textron Havoc recreational off-highway vehicles manufactured by Arctic Cat. The two-seat vehicles come in four color combinations: charcoal metallic/bronze, green/black, red/black or white/black. The vehicles have Textron Off Road printed on each side of the hood and Havoc on each side of the rear cargo box.

CPSCMay 22, 2019Nationwide• Arctic Cat Inc., of Thief River Falls, Minn., a subsidiary of Textron Specialized Vehicles, of Augusta, Ga.

DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany: DRG Salivary Testosterone ELISA- IVD for the detection of...

Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower

FDAMay 21, 2019Nationwide• DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany

Pasteurized Donor Breast Milk (Mothers' Milk Bank) – Microbiological Contamination (2019)

Positive microbiological culture for bacillus cereus

Class IHigh

FDAMay 20, 2019TX• Mothers' Milk Bank at Austin

Stay Informed

Baxter Healthcare Corporation Recalls

Recall Summary

Sevoflurane (Baxter Healthcare) – stability specification failure (2019)

Beckman Coulter Inc.: SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Cat...

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: Human Assayed Multi-Sera Level 2, Model NO. HN1530 Pro...

AmazonBasics Ceramic Space Heaters – Fire Hazard (2019)

Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom: Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Parivar Dry Dates – High Sulfite Levels (2019)

DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany: DRG Salivary Progesterone HS ELISA- IVD for the determina...

Whole Jalapeno (Shelton Farms) – Salmonella contamination (2019)

Baxter Healthcare Corporation: REVACLEAR 400 Dialyzer, Product Code 114746L Revaclea...

Baxter Healthcare Corporation: REVACLEAR 300 Dialyzer, Product Code 114745L Revaclea...

Boston Scientific Neuromodulation Corporation: Nitinol Thermocouple Electrode, 10 cm - Product Usage: Th...

Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom: Quantum Pump Console

Abbott Laboratories: ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITEC...

Abbott Laboratories: ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT ...

Pineapple Corer & Slicer (Fabulous Home) – laceration risk (2019)

Obalon Therapeutics Inc: Obalon Balloon System with Model 4300 Touch Dispenser Tou...

Abbott Laboratories: "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R0...

Havoc ROV (Arctic Cat) – Crash Hazard (2019)

DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany: DRG Salivary Testosterone ELISA- IVD for the detection of...

Pasteurized Donor Breast Milk (Mothers' Milk Bank) – Microbiological Contamination (2019)

Abbott Laboratories: "HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R0...